MDR 2017/745 consolidated with regulations 2023-607 and 2020-561

CSDmed is proud to present our latest novelty: a consolidated version of European Regulation 2017/745, now fully integrated with amendments 2023-607 and 2020-561 (in English).

🇪🇺 Our mission is to help you easily navigate the complex set of rules and regulations that govern the medical field.

The context :

European regulation MDR 2017/745 relating to medical devices (MD) came into force on May 26, 2021. The new regulations on medical devices have been strengthened in several areas:

- The requirements imposed on manufacturers before marketing a MD have been strengthened. Manufacturers will be required to implement evaluations and clinical investigations to ensure the effectiveness and safety of use of these devices for the benefit of the patient.

- Furthermore, the transparency of data has been reinforced thanks to a new European database called Eudamed, which contains detailed information about medical devices available in Europe and allows, among other things, to know the incidents declared as well as the progress of investigations clinics.

- Finally, the authorization procedures for notified bodies responsible for issuing CE markings and post-marketing market surveillance have been significantly strengthened.

Amendment 2020-561

MDR 2017/745 was initially planned for implementation on May 26, 2020. It was postponed for one year due to the major health crisis of COVID-19 in 2020. Indeed, given the scale of this crisis, the European authorities have decided to postpone the implementation of the MDR by 12 months. This decision was published on April 24, 2020 through Regulation (EU) 2020/561 which amends Regulation (EU) 2017/745 with regard to the dates of application of certain of its provisions including the postponed date of application to May 26, 2021.

Amendment 2023-607

Article 120 of MDR 2017/745 concerns “legacy devices”, which can, thanks to amendment 2023-607, continue to be placed on the market until a later date. However, the definition of “legacy devices” has also been modified in this amendment. Aside from the dates that have been extended in section 120 (December 31, 2027 for Class III legacy devices and certain Class IIb implantable devices, and December 31, 2028 for other legacy devices), two additional conditions have been added:

– the manufacturer must have made a request for conformity assessment according to the MDR to a notified body (NB) before May 26, 2024, and there must be an agreement signed with the NB before 26 September 2024; And

– no later than September 26, 2024, surveillance audits must be carried out by the NB which issues the certification according to the MDR, and this must also be manifested through the agreement signed with the NB.

In summary, from May 26, 2024 at the latest, or as soon as you have applied for certification according to the MDR from an NB at the earliest, the technical documentation of a legacy device must be both compliant with the MDD and MDR.

Why consolidate the MDR?

Thanks to this new tool, you will have quick and reliable access to the most recent regulations on medical devices in the European Union.

Our consolidated version of the regulations offers you not only the full text, but also an interactive summary. The latter allows you to easily navigate through the regulations, taking you directly to the chapters, articles, or annexes that interest you. No more wasting time searching for the information you need by scrolling through the text page by page - it's now just a click away.

At CSDmed, we understand the importance of staying up to date with legislative changes. This is why we have integrated amendments 2023-607 and 2020-561 into our consolidated version of European Regulation 2017/745. These amendments, crucial for medical device manufacturers, are now easily accessible and readable in context.

Don't miss this opportunity to access accurate, up-to-date and easy-to-use information.

Join the CSDmed community and get a head start on European medical device legislation.

Welcome aboard, and happy sailing! 🛳️🌐

Download the English file by clicking on thislink

Téléchargez le fichier en français en cliquant sur celien

Our Expertise

Since the arrival of Regulation 2017/745, new requirements have been requested and are part of the documentation to be presented to the notified body (e.g. in-depth review of the clinical evaluation, PMS procedure, QC results from products validation, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its customers, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to handle the MDR transition in its entirety.

🔗 Contact us and find out how we can help you.

Download the English file by clicking on thislink

Téléchargez le fichier en français en cliquant sur celien